20 April 2016 - With access to claims data on about 200 million patients and 5.5 billion patient encounters across the United States, the US FDA’s Sentinel Initiative has grown into a juggernaut of patient experience since its pilot program launched in 2008.

The pilot phase, Mini Sentinel, met a FDA Amendments Act (FDAAA) requirement to create an active drug safety monitoring system. Created as a public-private partnership, the system would give the FDA the ability to query patient data while still protecting patient privacy. The FDA contracted the Harvard Pilgrim Health Care Institute to be the initiative’s operating center, which interacts directly with Sentinel’s 18 data partners, predominantly major health insurers recruited to provide access to data on large swaths of US patients. The center has also worked to develop and refine the methods for querying partners’ data.

In the past year, the system has transitioned out of the “mini” phase, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said during the annual Sentinel Initiative Public Workshop hosted in February by the Duke-Margolis Center for Health Policy.

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